Brand Name | MCKESSON BRANDS |
Type of Device | SYRINGE LL 5CC |
Manufacturer (Section D) |
JIANGSU CAINA MEDICAL CO.,LTD |
no.23 huanxi rd |
zhutang town |
jiangyin city, 20180 3 |
CH 201803 |
|
MDR Report Key | 8950108 |
MDR Text Key | 156909440 |
Report Number | 1451040-2019-00008 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial,Followup |
Report Date |
08/30/2019,09/11/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 16-S5C |
Device Lot Number | CJCH12-01 |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 08/21/2019 |
Device Age | 8 MO |
Date Report to Manufacturer | 08/30/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/30/2019 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/11/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|